Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition: A Prospective, Multicenter, Phase III Randomized Control Clinical Trial
This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy of standard nutrition treatment versus conventional nutrition treatment in local advanced nasopharyngeal carcinoma patients.
• Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III);
• All genders,range from 18~65 years old;
• Karnofsky performance status(KPS) ≥ 80;
• Clinical stage III\
⁃ IVa(AJCC/UICC 8th);
• Without significant digestive system disease,nutritional and metabolic diseases or endocrine disease
• Without significant cardiac,respiratory,kidney or liver disease;
• Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy);
• White blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, Hemoglobin(HGB) ≥ 9g/L, platelet(PLT) count ≥ 100×109/L
• Total bilirubin(TBIL)、alanine aminotransferase (ALT) or aspartate aminotransferase(AST) \< 2.5×upper limit of normal(ULN);
• Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
• No contraindications to chemotherapy or radiotherapy;
• Inform consent form;